Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the response rate and maximum response in patients with relapsed or refractory Hodgkin's lymphoma treated with gemcitabine, cisplatin, and dexamethasone. - Determine time to progression in patients treated with this regimen who are not undergoing stem cell transplantation. - Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gemcitabine IV over 1 hour on days 1 and 8, cisplatin IV over 3 hours on day 1, and oral dexamethasone twice daily on days 1-4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed until disease progression. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of Hodgkin's lymphoma - Measurable disease by radiological or clinical findings - Failed at least 1, but no more than 2, prior standard chemotherapy regimens - High-dose chemotherapy administered after a chemotherapy course is considered 2 courses - No evidence of CNS disease - No history of myelodysplastic syndromes PATIENT CHARACTERISTICS: Age - Over 18 Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC > 2,000/mm^3 - Absolute neutrophil count > 1,500/mm^3 - Platelet count > 75,000/mm^3 - Hemoglobin > 8.0 g/dL Hepatic - Bilirubin < 2 times upper limit of normal (ULN) - AST and ALT < 5 times ULN Renal - Creatinine < 1.5 times ULN Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior gemcitabine - More than 6 months since prior high-dose chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00090909


Primary Contact:

Study Chair
Christos E. Emmanouilides, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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